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Executive Summary

CTFA REITERATES PLEA FOR FASEB PEER REVIEW OF COLOR ADDITIVE safety issues prior to a final decision in an Oct. 22 letter to FDA Com. Young. The letter was sparked by the recent congressional hearing at which Young said he is preparing to make recommendations on the safety of D&C Red Nos. 9, 19 and D&C Orange No. 17, among others. It is likely that he will advise banning the dyes as his predecessor, Acting Com. Novitch, did. CTFA's letter also concerned FD&C Red No. 3. "We believe . . . there are reasonable scientific questions that must fully be explored through independent peer review" before a decision is made, CTFA President Edward Kavanaugh told Young. The assn. was reiterating an Aug. 31 request to Young that certain science issues be referred to an outside review body -- specifically the Federation of American Societies for Experimental Biology (FASEB). "FDA already has a contract with FASEB under which such peer review is to be conducted for issues involving food additives and color additives," the assn. continued, adding: "No substantial delay need be incurred by such a review. Accordingly, we urge that you promptly submit them for review and consideration by FASEB." The current provisional listing closing date for the four colors is Dec. 3. "One of the issues to be considered in such a review would be the possibility of obtaining additional scientific evidence, in the short term, which would resolve any remaining ambiguities or concerns" relating to the safety of the dyes, CTFA's Kavanaugh said. For example, CTFA continued, at a public speech in March, Center for Food Safety and Applied Nutrition Director Sanford Miller mentioned "the possibility of conducting short-term in vitro studies on any suspect constituents of the four color additives, to determine whether a constituent or the color additive itself was responsible for the carcinogenic effects." Other testing of this nature "might also be suggested," CTFA pointed out, adding: "A fresh look by independent scientists would benefit both the agency and the industry." The four dyes have been linked to carcinogenic responses in animal tests. CTFA's 17-page letter went to Young along with two other documents: a "summary of the regulatory status" of the four additives, including the general results of bioassays and quantitative risk assessments on the dyes, and a recently prepared report by an outside consultant on the "selective penetration" and "inconsistent mixture" issues as related to the safety of the compounds.

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